Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination
A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma...
Brief Summary
Official Title: “A Phase I Open Label Study to Asses the Safety and Tolerability of ZD6474 (Vandetanib)in Combination With Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as First or Second Line Therapy in Patients With Metastatic Colorectal Adenocarcinoma.”
A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: May 2006
Intervention(s) in this Clinical Trial
- Drug: ZD6474 (vandetanib)
- once daily oral tablet
- Drug: Irinotecan
- intravenous infusion
- Drug: 5-Fluorouracil
- intravenous infusion
- Drug: Leucovorin
- intravenous infusion
Outcome Measures for this Clinical Trial
Primary Measures
- Establish the safety & efficacy of ZD6474 w/5-fluorouracil,leucovorin & oxaliplatin to patients with advanced colorectal adenocarcinoma, by assessment of AEs, vital signs, clinical chemistry, hematology, urinalysis, ECG and physical examinations
- Time Frame: assessed at each visit
Safety Issue?: No
- Time Frame: assessed at each visit
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- 1. Confirmed metastatic colorectal adenocarcinoma
- 2. Not amenable to surgery or radiation therapy
- 3. For first or second line chemotherapy
Exclusion Criteria:
- 1. Brain metastases or spinal compression
- 2. Last prior chemotherapy discontinued within 4 weeks before start
- 3. Last dose radiotherapy within 4 weeks of start
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
Mark Saunders, MD Principal Investigator AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00507091
Study ID Number: D4200C00038
ClinicalTrials.gov Identifier: NCT00507091
Health Authority: United Kingdom: National Health Service
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00507091
